What is Tobramycine SUN?
Tobramycine SUN is an aminoglycoside (ah-meen-oh-GLY-ko-side) antibiotic. Tobramycine SUN fights infections that are caused by bacteria.
Tobramycine SUN inhalation is inhaled into the lungs using a nebulizer. Tobramycine SUN inhalation is used to treat lung infections in patients with cystic fibrosis.
Tobramycine SUN inhalation is for use in adults and children who are at least 6 years old.
Tobramycine SUN inhalation may also be used for purposes not listed in this medication guide.
Tobramycine SUN indications
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycine SUN injection and other antibacterial drugs, Tobramycine SUN injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Tobramycine SUN injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli, and Klebsiella sp.
Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains).
Serious central nervous system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp.
Skin, bone and skin-structure infections caused by P. aeruginosa, Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus.
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp.
Aminoglycosides, including Tobramycine SUN, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycine SUN may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to Tobramycine SUN. If susceptibility tests show that the causative organisms are resistant to Tobramycine SUN, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with Tobramycine SUN sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with Tobramycine SUN should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGS box above.
How should I use Tobramycine SUN?
Use Tobramycine SUN ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Remove contact lenses before you use Tobramycine SUN ointment.
- Do not wear contact lenses while you are using Tobramycine SUN ointment. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
- Tobramycine SUN ointment may be used around the eye or in the eye. To use Tobramycine SUN ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Tobramycine SUN ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- To clear up your infection completely, take/use Tobramycine SUN ointment for the full course of treatment. Keep taking/using it even if you feel better in a few days.
- Tobramycine SUN ointment works best if it is used at the same time each day.
- Do not miss any doses. If you miss a dose of Tobramycine SUN ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Ask your health care provider any questions you may have about how to use Tobramycine SUN ointment.
Uses of Tobramycine SUN in details
Use: Labeled Indications
Cystic fibrosis: Management of cystic fibrosis in adults and pediatric patients ≥6 years of age with Pseudomonas aeruginosa.
Limitations of use: Safety and efficacy have not been demonstrated in patients with FEV <25% or >75% predicted (Tobramycine SUN; Tobramycine SUN), or in patients colonized with Burkholderia cepacia.
Off Label Uses
Non-cystic fibrosis bronchiectasis
According to a national consensus summary and international guidelines, aerosolized Tobramycine SUN should not be used for the treatment and prevention of non-cystic fibrosis bronchiectasis. Aerosolized antibiotics may be considered in patients who have experienced 3 or more exacerbations requiring antibiotic therapy per year; organism sensitivity should be considered when choosing an antibiotic. The risk of adverse events, cost of therapy, and patient status should be considered prior to initiating aerosolized Tobramycine SUN because the efficacy of aerosolized Tobramycine SUN in the treatment of non-cystic fibrosis bronchiectasis has not been well documented.
Tobramycine SUN description
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the pseudomonas species. It is a 10% component of the antibiotic complex, nebramycin, produced by the same species. [PubChem]
Tobramycine SUN dosage
Tobramycine SUN Dosage
Generic name: Tobramycine SUN 300mg in 5mL
Dosage form: inhalation solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Dosing Information
- Tobramycine SUN is a co-packaging of Tobramycine SUN inhalation solution ampules with a PARI LC PLUS Reusable Nebulizer. Administer as follows: One single-use ampule (300 mg /5 mL) of Tobramycine SUN inhalation solution twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug.
- The 300 mg/5mL dose of Tobramycine SUN inhalation solution is the same for all patients regardless of age or weight.
- The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
Administration of Tobramycine SUN Inhalation Solution
Each dose of Tobramycine SUN inhalation solution is administered by oral inhalation using only the co-packaged PARI LC PLUS Reusable Nebulizer (Model No. 022B81-T) included in the Tobramycine SUN, along with a DeVilbiss Pulmo-Aide air compressor (Model No. 5650D).
Tobramycine SUN inhalation solution is not for subcutaneous, intravenous or intrathecal administration.
Prior to administration, read the Patient Information/Instructions for Use for Tobramycine SUN for detailed information on how to use Tobramycine SUN and follow the manufacturer's instructions for use and care of the DeVilbiss Pulmo-Aide air compressor.
The entire Tobramycine SUN inhalation solution treatment should take approximately 15 minutes to complete. Continue treatment until all the Tobramycine SUN inhalation solution has been delivered, and there is no longer any mist being produced.
Tobramycine SUN inhalation solution should not be diluted or mixed with other drugs including dornase alfa (Pulmozyme®) in the nebulizer. Instruct patients on multiple therapies to take their medications prior to inhaling the Tobramycine SUN inhalation solution, or as directed by their physician.
Tobramycine SUN inhalation solution should not be used if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days.
More about Tobramycine SUN (Tobramycine SUN)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- 0 Reviews - Add your own review/rating
- Generic Availability
Consumer resources
- Tobramycine SUN (Advanced Reading)
- Other brands: Tobramycine SUN, Bethkis, Tobramycine SUN, Nebcin
Professional resources
- Tobramycine SUN (FDA)
- Tobramycine SUN Sulfate (AHFS Monograph)
Related treatment guides
- Cystic Fibrosis
Tobramycine SUN interactions
See also:
What other drugs will affect Tobramycine SUN?
No clinical drug interaction studies have been performed with Tobramycine SUN. In clinical studies, patients receiving Tobramycine SUN continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides. No clinical signs of drug interactions with these medicines were identified.
Concurrent and/or sequential use of Tobramycine SUN with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.
Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Tobramycine SUN should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and Tobramycine SUN has not been evaluated.
Tobramycine SUN side effects
See also:
What are the possible side effects of Tobramycine SUN?
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tobramycine SUN has been evaluated for safety in 425 cystic fibrosis patients exposed to at least one dose of Tobramycine SUN, including 273 patients who were exposed across three cycles (6 months) of treatment. Each cycle consisted of 28 days on-treatment (with 112 mg administered twice-daily) and 28 days off-treatment. Patients with serum creatinine ≥2 mg/dL and blood urea nitrogen (BUN) ≥40 mg/dL were excluded from clinical studies. There were 218 males and 207 females in this population, and reflecting the cystic fibrosis population in the U.S., the vast majority of patients were Caucasian. There were 221 patients ≥20 years old, 121 patients ≥13 to <20 years old, and 83 patients ≥6 to <13 years old. There were 239 patients with screening FEV1 % predicted ≥50%, 156 patients with screening FEV1 % predicted <50%, and 30 patients with missing FEV1 % predicted.
The primary safety population reflects patients from Study 1, an open-label study comparing Tobramycine SUN with Tobramycine SUN (Tobramycine SUN inhalation solution, USP) over three cycles of 4 weeks on treatment followed by 4 weeks off treatment. Randomization, in a planned 3:2 ratio, resulted in 308 patients treated with Tobramycine SUN and 209 patients treated with Tobramycine SUN. For both the Tobramycine SUN and Tobramycine SUN groups, mean exposure to medication for each cycle was 28 to 29 days. The mean age for both arms was between 25 and 26 years old. The mean baseline FEV1 % predicted for both arms was 53%.
Table 1 displays adverse drug reactions reported by at least 2% of Tobramycine SUN patients in Study 1, inclusive of all cycles (on and off treatment). Adverse drug reactions are listed according to MedDRA system organ class and sorted within system organ class group in descending order of frequency.
| 1This includes adverse events of pulmonary or cystic fibrosis exacerbations | ||
| Primary System Organ Class Preferred Term | Tobramycine SUN N=308 % | Tobramycine SUN N=209 % |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 48.4 | 31.1 |
| Lung disorder1 | 33.8 | 30.1 |
| Productive cough | 18.2 | 19.6 |
| Dyspnea | 15.6 | 12.4 |
| Oropharyngeal pain | 14.0 | 10.5 |
| Dysphonia | 13.6 | 3.8 |
| Hemoptysis | 13.0 | 12.4 |
| Nasal congestion | 8.1 | 7.2 |
| Rales | 7.1 | 6.2 |
| Wheezing | 6.8 | 6.2 |
| Chest discomfort | 6.5 | 2.9 |
| Throat irritation | 4.5 | 1.9 |
| Gastrointestinal disorders | ||
| Nausea | 7.5 | 9.6 |
| Vomiting | 6.2 | 5.7 |
| Diarrhea | 4.2 | 1.9 |
| Dysgeusia | 3.9 | 0.5 |
| Infections and infestations | ||
| Upper respiratory tract infection | 6.8 | 8.6 |
| Investigations | ||
| Pulmonary function test decreased | 6.8 | 8.1 |
| Forced expiratory volume decreased | 3.9 | 1.0 |
| Blood glucose increased | 2.9 | 0.5 |
| Vascular disorders | ||
| Epistaxis | 2.6 | 1.9 |
| Nervous system disorders | ||
| Headache | 11.4 | 12.0 |
| General disorders and administration site conditions | ||
| Pyrexia | 15.6 | 12.4 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal chest pain | 4.5 | 4.8 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 2.3 | 2.4 |
Adverse drug reactions that occurred in <2% of patients treated with Tobramycine SUN in Study 1 were: bronchospasm (Tobramycine SUN 1.6%, Tobramycine SUN 0.5%); deafness including deafness unilateral (reported as mild to moderate hearing loss or increased hearing loss) (Tobramycine SUN 1.0%, Tobramycine SUN 0.5%); and tinnitus (Tobramycine SUN 1.9%, Tobramycine SUN 2.4%).
Discontinuations in Study 1 were higher in the Tobramycine SUN arm compared to Tobramycine SUN (27% Tobramycine SUN versus 18% Tobramycine SUN). This was driven primarily by discontinuations due to adverse events (14% Tobramycine SUN versus 8% Tobramycine SUN). Higher rates of discontinuation were seen in subjects ≥20 years old and those with baseline FEV1 % predicted <50%.
Respiratory related hospitalizations occurred in 24% of the patients in the Tobramycine SUN arm and 22% of the patients in the Tobramycine SUN arm. There was an increased new usage of antipseudomonal medication in the Tobramycine SUN arm (65% Tobramycine SUN versus 55% Tobramycine SUN). This included oral antibiotics in 55% of Tobramycine SUN patients and 40% of Tobramycine SUN patients and intravenous antibiotics in 35% of Tobramycine SUN patients and 33% of Tobramycine SUN patients. Median time to first antipseudomonal usage was 89 days in the Tobramycine SUN arm and 112 days in the Tobramycine SUN arm.
The supportive safety population reflects patients from two studies: Study 2, a double-blind, placebo-controlled design for the first treatment cycle, followed by all patients receiving Tobramycine SUN (replaced placebo) for two additional cycles, and Study 3, a double-blind, placebo-controlled trial for one treatment cycle only. Placebo in these studies was inhaled powder without the active ingredient, Tobramycine SUN. The patient population for these studies was much younger than in Study 1 (mean age 13 years old).
Adverse drug reactions reported more frequently by Tobramycine SUN patients in the placebo-controlled cycle (Cycle 1) of Study 2, which included 46 Tobramycine SUN and 49 placebo patients, were:
Respiratory, thoracic, and mediastinal disorders
Pharyngolaryngeal pain (Tobramycine SUN 10.9%, placebo 0%); dysphonia (Tobramycine SUN 4.3%, placebo 0%)
Gastrointestinal disorders
Dysgeusia (Tobramycine SUN 6.5%, placebo 2.0%)
Adverse drug reactions reported more frequently by Tobramycine SUN patients in Study 3, which included 30 Tobramycine SUN and 32 placebo patients, were:
Respiratory, thoracic, and mediastinal disorders
Cough (Tobramycine SUN 10%, placebo 0%)
Ear and labyrinth disorders
Hypoacusis (Tobramycine SUN 10%, placebo 6.3%)
Audiometric Assessment
In Study 1, audiology testing was performed in a subset of approximately 25% of Tobramycine SUN (n=78) and Tobramycine SUN (n=45) patients. Using the criteria for either ear of ≥10 dB loss at two consecutive frequencies, ≥20 dB loss at any frequency, or loss of response at three consecutive frequencies where responses were previously obtained, five Tobramycine SUN patients and three Tobramycine SUN patients were judged to have ototoxicity, a ratio similar to the planned 3:2 randomization for this study.
Audiology testing was also performed in a subset of patients in both Study 2 (n=13 from the Tobramycine SUN group and n=9 from the placebo group) and Study 3 (n=14 from the Tobramycine SUN group and n=11 from the placebo group). In Study 2, no patients reported hearing complaints but two Tobramycine SUN patients met the criteria for ototoxicity. In Study 3, three Tobramycine SUN and two placebo patients had reports of ‘hypoacusis.’ One Tobramycine SUN and two placebo patients met the criteria for ototoxicity. In some patients, ototoxicity was transient or may have been related to a conductive defect.
Cough
Cough is a common symptom in cystic fibrosis, reported in 42% of the patients in Study 1 at baseline. Cough was the most frequently reported adverse event in Study 1 and was more common in the Tobramycine SUN arm (48% Tobramycine SUN versus 31 % Tobramycine SUN). There was a higher rate of cough adverse event reporting during the first week of active treatment with Tobramycine SUN (i.e., the first week of Cycle 1). The time to first cough event in the Tobramycine SUN and Tobramycine SUN groups were similar thereafter. In some patients, cough resulted in discontinuation of Tobramycine SUN treatment. Sixteen patients (5%) receiving treatment with Tobramycine SUN discontinued study treatment due to cough events compared with 2 (1%) in the Tobramycine SUN treatment group. Children and adolescents coughed more than adults when treated with Tobramycine SUN, yet the adults were more likely to discontinue: of the 16 patients on Tobramycine SUN in Study 1 who discontinued treatment due to cough events, 14 were ≥20 years of age, one patient was between the ages of 13 and <20, and one was between the ages of 6 and <13. The rates of bronchospasm (as measured by ≥20% decrease in FEV1 % predicted post-dose) were approximately 5% in both treatment groups, and none of these patients experienced concomitant cough.
In Study 2, cough was the most commonly reported adverse event during the first cycle of treatment (the double blind period of treatment) and occurred more frequently in placebo-treated patients (26.5%) than patients treated with Tobramycine SUN (13%). Similar percentages of patients in both treatment groups reported cough as a baseline symptom. In Study 3, cough events were reported by three patients in the Tobramycine SUN group (10%) and none in the placebo group (0%).
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Tobramycine SUN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Respiratory, thoracic, and mediastinal disorders
Aphonia, Sputum discolored
General disorders and administration site conditions
Malaise
Tobramycine SUN contraindications
See also:
What is the most important information I should know about Tobramycine SUN?
A hypersensitivity to any aminoglycoside is a contraindication to the use of Tobramycine SUN. A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.
Active ingredient matches for Tobramycine SUN:
Tobramycin in Netherlands.
List of Tobramycine SUN substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Tobramycine-Mayne (Luxembourg) | |
| Tobramysil (Bulgaria) | |
| Tobran | |
| Tobran 40 mg Injection (Redson Pharmaceuticals) | $ 0.53 |
| Tobranax (Venezuela) | |
| Tobraneg (India) | |
| TOBRANEG Injection / 80mg / 2ml units (Elder Pharmaceuticals Pvt Ltd) | $ 0.72 |
| TOBRANEG Injection / 20ml / 2ml units (Elder Pharmaceuticals Pvt Ltd) | $ 0.34 |
| TOBRANEG Injection / 60mg / 1.5ml units (Elder Pharmaceuticals Pvt Ltd) | $ 0.60 |
| Tobraneg 20mg/2mL VIAL / 1 (Elder Pharmaceuticals Pvt Ltd) | $ 0.48 |
| Tobraneg 60mg/1.5mL VIAL / 1 (Elder Pharmaceuticals Pvt Ltd) | $ 0.66 |
| Tobraneg 80mg/2mL VIAL / 1 (Elder Pharmaceuticals Pvt Ltd) | $ 0.80 |
| 20 mg x 2 mL x 1's (Elder Pharmaceuticals Pvt Ltd) | $ 0.48 |
| 60 mg x 1.5 mL x 1's (Elder Pharmaceuticals Pvt Ltd) | $ 0.66 |
| 80 mg x 2 mL x 1's (Elder Pharmaceuticals Pvt Ltd) | $ 0.80 |
| Tobraneg 80 mg Injection (Elder Pharmaceuticals Pvt Ltd) | $ 0.84 |
| Tobraneg 20 mg Injection (Elder Pharmaceuticals Pvt Ltd) | $ 0.28 |
| Tobraneg 60 mg Injection (Elder Pharmaceuticals Pvt Ltd) | $ 0.60 |
| TOBRANEG 20MG INJECTION 1 vial / 2 ML injection each (Elder Pharmaceuticals Pvt Ltd) | $ 0.49 |
| TOBRANEG 20MG INJECTION 1 vial / 2 ML injection each (Elder Pharmaceuticals Pvt Ltd) | $ 0.49 |
| TOBRANEG 60MG INJECTION 1 vial / 1 ML injection each (Elder Pharmaceuticals Pvt Ltd) | $ 0.69 |
| TOBRANEG 80MG INJECTION 1 vial / 2 ML injection each (Elder Pharmaceuticals Pvt Ltd) | $ 0.87 |
| TOBRANEG inj 20 mg x 2 mL x 2ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.48 |
| TOBRANEG inj 60 mg x 1.5 mL x 1.5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.72 |
| TOBRANEG inj 80 mg x 2 mL x 2ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.87 |
| Tobraneg 20mg Injection (Elder Pharmaceuticals Pvt Ltd) | $ 0.25 |
| Tobraneg 60mg Injection (Elder Pharmaceuticals Pvt Ltd) | $ 0.69 |
| Tobraneg 80mg Injection (Elder Pharmaceuticals Pvt Ltd) | $ 0.41 |
| TOBRANEG (ELI LILLY) | |
| TOBRANEG 10MG INJECTION 1 vial / 2 ML injection each (Eli Lilly and Company India Pvt Ltd) | $ 0.69 |
| TOBRANEG 60MG INJECTION 1 vial / 1 ML injection each (Eli Lilly and Company India Pvt Ltd) | $ 0.48 |
| TOBRANEG 60MG INJECTION 1 vial / 2 ML injection each (Eli Lilly and Company India Pvt Ltd) | $ 0.52 |
| TOBRANEG 80MG INJECTION 1 vial / 2 ML injection each (Eli Lilly and Company India Pvt Ltd) | $ 0.83 |
| Tobranet (Argentina) | |
| Tobranom (Brazil) | |
| Tobraoftal (Colombia) | |
| TOBRAPIC | |
| TOBRAPIC EYE DROP 1 packet / 10 ML eye drop each (PCI Pharmaceuticals) | $ 0.12 |
| Tobrased (Turkey) | |
| Tobrasix (Austria) | |
| Injectable; Injection; Tobramycin Sulfate 10 mg / ml (Lilly) | |
| Injectable; Injection; Tobramycin Sulfate 40 mg / ml (Lilly) | |
| Injectable; Injection; Tobramycin Sulfate 80 mg / ml (Lilly) | |
| Tobrasix 160 mg/2 ml (Austria) | |
| Tobrastill (Georgia, Italy) | |
| Tobravis (Bosnia & Herzegowina) | |
| Tobravisc (Belgium, Luxembourg, United Kingdom) | |
See 947 substitutes for Tobramycine SUN | |
References
- DailyMed. "TOBRAMYCIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "tobramycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "tobramycin". http://www.drugbank.ca/drugs/DB00684 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Tobramycine SUN are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tobramycine SUN. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
